FAQ

What is locality authorisation?

The term Locality Authorisation refers specifically to the process used by the NZ Health and Disability Ethics Committees (HDECs) for ascertaining that all local governance issues have been addressed at sites participating in a research project.

If Auckland DHB is a site for your research project (ie, one or more of the procedures described in the study protocol will be conducted at Auckland DHB) and your project requires approval from an HDEC, then you will need to request a Locality Authorisation from Auckland DHB via the HDEC online application system Online Forms(external link)

How to submit an HDEC annual progress report (or other HDEC Post-approval Form)

If you have an HDEC approval for your research it is a condition of that approval that you report on progress to HDEC, at least annually, until the conclusion of the study. When HDEC reviews and approves your annual progress report it will post a downloadable "Approved annual progress report" letter in the report's e-Submission screen. The letter will feature the next due date for annual reporting (typically 12 months since the previous due date) in bold. If your HDEC-approved study is active at Auckland DHB and you have an Auckland DHB locality authorisation (see above), the Research Office will be able to check that you are submitting annual reports in a timely way. Your Auckland DHB approval will be withdrawn if you don't respond to reminders to do so. Make sure you know your next due date for annual reporting and aim to submit the report two to three weeks prior to that date to give HDEC time to process.

All other HDEC Post-approval Forms (amendments, protocol violations, final reports etc.) are submitted (when required) via HDEC Online Forms in the same way as annual progress reports. Here's a guide for how to navigate the online system and submit your reports...

Institutional approval

This is NOT the same as ethics approval or HDEC locality authorisation.

Clinical research conducted on the premises of Auckland District Health Board or involving its patients, clients or staff, is important to Auckland DHB. There are financial, human resource, ethical, legal, planning, quality and risk issues. The primary role of the Research Office is to provide a service to investigators and management to address these issues in accordance with Auckland DHB Policies and procedures.

You may not start your research project until you receive institutional approval from the Auckland DHB Research Office.

Not sure if you need ethics review?

If your study involves human participants it may need to be approved by an ethics committee before you can start. There are two kinds of ethics committees in New Zealand; Health and Disability Ethics Committees (HDECs) and institutional ethics committees. The Auckland Health Research Ethics Committee (AHREC) is Auckland DHB's institutional ethics committee.

Ethics committees check that proposed health and disability research meets established ethical standards that aim to protect participants who are either patients, their family/whaanau/caregivers, staff or volunteers in clinical trials.

Most health research and all high risk clinical research must be approved by an HDEC. Full HDEC review is always required when a study involves one of the following:

A new medicine (as defined by the Medicines Act 1981), or

An approved medicine being used for a new indication or through a new mode of administration, or

Medical devices that are or would be classified as a class IIb, class III or active implantable medical device by the TGA, or

New surgical interventions, or

One or more participants who will not have given informed consent to participate, or

One or more participants who are vulnerable (that is, who have restricted capability to make independent decisions about their participation in the study), or

Standard treatment being withheld from one or more participants, or

The storage, preservation or use of human tissue without consent.

Expedited HDEC review may be required for studies not including the above features but that are "more than minimal risk". For research that is "out of scope" for HDEC (not more than minimal risk) then the AHREC may review and approve the study.

If you will NOT be obtaining informed consent to use identified patient information, and any of the below apply, you will need expedited ethical approval from a HDEC.

You are not employed by or contracted to Auckland DHB.

You will be retaining unique identifiers (e.g. NHI) in your dataset that could link to other databases or registries.

You will be obtaining health information from other health care organisations in addition to ADHB.

Even if you do not require HDEC approval for your research, you should check whether your institution requires that you obtain approval from the relevant institutional ethics committee.

What is an audit?

An audit is an independent review and examination of records and activities to assess the adequacy of system controls, to ensure compliance with established policies, operational procedures, and/or evidence based standards of care and to recommend, where necessary changes in controls, policies, or procedures to ensure those standards are met.

What are educational projects?

A set of formal and structured educational requirements leading to an established designation or competency i.e degree. (May require ethical approval from Educational Institution Ethics Committee and/or the Health & Disability Ethics Committee).

What is quality assurance?

The formal and systematic monitoring and reviewing of medical care delivery and outcome; designing activities to improve healthcare and overcome identified deficiencies in providers, facilities, or support systems; and carrying out follow-up steps or procedures to ensure that actions have been effective and no new problems have been introduced.

What is research?

Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalisable knowledge.(Requires ethical approval).